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Completed

NCT Number: NCT03671603

Post-Marketing Safety Study in ST-Segment Elevation Myocardial Infarction (STEMI) Participants Undergoing Primary Percutaneous Coronary Intervention (PCI) Procedure With VISIPAQUE® as the Contrast Medium

The purpose of this study is to prospectively observe the incidence rate of acute kidney injury (AKI), major adverse renal and cardiovascular events (MARCE) in participants who were diagnosed with ST-segment elevation myocardial infarction (STEMI) and have completed primary percutaneous coronary intervention (PCI) procedure following an injection of iso-osmolar contrast medium iodixanol (Visipaque) during the in-hospital period and up to 30 days post-PCI follow-up period. The study will provide a better safety profile of Visipaque as the contrast medium in PCI procedure.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction ST-segment Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaifeng Central Hospital, Kaifeng, Contact:, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants may be included in the study if they meet all of the following criteria:

  • The participant is over 18 years' old
  • The participant with ST segment elevation myocardial infarction (STEMI) diagnosis has completed primary percutaneous coronary intervention (PCI) procedure and Visipaque was used as the contrast medium in the procedure
  • The participant completed pre-procedural serum creatinine (SCr) test at the same hospital where PCI procedure was conducted, and the SCr test should be conducted with the same methodology before and after the procedure
  • The participant has signed and dated the written informed consent form

Exclusion criteria

Participants must be excluded from participating in this study if they meet any of the following criteria:

  • The participant has any contraindications to Visipaque (e.g., manifest thyrotoxicosis, history of serious hypersensitivity reaction to iodinated contrast media)
  • The participant is pregnant or lactating
  • The participant has been previously enrolled in this study
  • The participant is currently under renal dialysis
  • The participant presents with a terminal (life expectation <1 month), serious, or life-threatening disease, or any medical or psychiatric condition, or any condition where study participation may compromise the management of the participant
  • The participant has other reasons that in the judgement of the investigator is unsuitable for participation in the study

Treatment and study plan

Iodixanol

Drug

Iodixanol 270 mgI/ml or 320 mg I/ml injection will be administered as part of clinical practice according to the judgment of the site with regard to medical need.

Other names: VISIPAQUE®

Primary outcomes

  1. Assessment of the Incidence Rate of AKI in STEMI Participants Undergoing Primary PCI Using Visipaque

    Time frame: Within 48-72 hours post PCI

    AKI which is defined as a serum creatinine (SCr) increase of ≥ 0.3 mg/dL (≥ 26.4 umol/L) or increase to ≥150% (≥1.5-fold) from baseline values within 48-72 hours.

Secondary outcomes

  1. Assessment of the Incidence Rate of MARCE in STEMI Participants Undergoing Primary PCI Using Visipaque Within 72 Hours Post-PCI

    Time frame: Within 72 hours post-PCI

    MARCE includes cardiac death, re-infarction, target lesion revascularization (TLR), stent thrombosis, unstable angina, stroke, transient ischemic attack (TIA), AKI, renal failure requiring dialysis.

  2. Assessment of the Incidence Rate of Each Event of MARCE (except AKI) in STEMI Participants Undergoing Primary PCI Using Visipaque Within 72 Hours Post-PCI

    Time frame: Within 72 Hours post-PCI

    MARCE includes cardiac death, re-infarction, TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis.

  3. Assessment of the Incidence Rate of MARCE (Except AKI) in STEMI Participants Undergoing Primary PCI Using Visipaque From 72 hours to 30 days Post-PCI

    Time frame: From 72 hours to 30 days post-PCI

    MARCE includes cardiac death, re-infarction,TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis.

  4. Assessment of the Incidence Rate of Each Event of MARCE (except AKI) in STEMI Participants Undergoing Primary PCI Using Visipaque From 72 hours to 30 Days Post-PCI

    Time frame: From 72 hours to 30 Days post-PCI

    MARCE includes cardiac death, re-infarction, TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis.

  5. All-Cause Mortality of STEMI Participants Within 30 days after primary PCI

    Time frame: From Baseline up to 30 days post-PCI

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

The Association of Iodixanol (Visipaque) to Renal Function and Cardiac and Cerebrovascular Events in STEMI Patients Undergoing Primary PCI: A Prospective, Multi-National, Multi-Center, Open-Label, Observational Study

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2018
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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